510(k) Report

FDA applicant

Btg International, Inc.

Bothell, WA6 decisions2014–20195 recalls

FDA records 6 decisions for Btg International, Inc. (Bothell, WA) from 2014 to 2019: 6 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and JXG (Shunt, Central Nervous System And Components). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 4 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Btg International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2014: 12017: 12018: 22019: 2
2014high 2 (2018) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2022

2015: 12016: 22020: 12022: 1
2014high 2 (2016) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Btg International, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Btg International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QEYMechanical Thrombolysis Catheter5decisions
  • JXGShunt, Central Nervous System And Components1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 0 of its 4 were faster than that.

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 20192cite it
  • K191119EkoSonic Endovascular DeviceBtg International, Inc. · 20192cite it
  • K182324EkoSonic Endovascular SystemBtg International, Inc. · 20181cites it
  • K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 20171cites it
  • K140151Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 20141cites it

What has FDA decided for it lately?

  • K191119EkoSonic Endovascular DeviceBtg International, Inc. · 2019
  • K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 20192 recalls
  • K182324EkoSonic Endovascular SystemBtg International, Inc. · 2018
  • K172035EKOS ultrasound EVD Device, EVD Control UnitBtg International, Inc. · 2018
  • K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 20171 recall
  • K140151Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 20143 recalls

All 6 as Btg International, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K162771EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a…Oct 13, 2022Class II
  • K183361EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS)…Nov 3, 2020Class II
  • K081467EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterAug 9, 2016Class II
  • K081467EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main…Jan 21, 2016Class II
  • K081467The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic…Jun 24, 2015Class II